Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125249
Company: KINIKSA PHARMACEUTICALS (UK), LTD.
Company: KINIKSA PHARMACEUTICALS (UK), LTD.
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARCALYST | RILONACEPT | 220MG | VIAL; SINGLE-USE | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/27/2008 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125249s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125249s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2021 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125249Orig1s049ltr.pdf | |
12/18/2020 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s047ltr.pdf | |
02/12/2020 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s045ltr.pdf | |
09/30/2010 | SUPPL-18 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2021 | SUPPL-49 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf | |
12/18/2020 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf | |
02/12/2020 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf | |
02/27/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf |